Cancer Cancer Head and neck cancer
Conditions
Interventions
Arm 1 - CHARTWEL radiotherapy. A total of 34 treatments of 1.5 Gy should be given three times per day, Monday to Friday in two consecutive weeks and the Monday and Tuesday of the following week (12
Sponsors
Medical Research Council (MRC) (UK)
Eligibility
Inclusion criteria
Inclusion criteria: 1. Surgically resected and histologically proven squamous cell carcinoma of the head and neck area at high or intermediate risk of recurrence within the head and neck region 2. Elective surgery performed with the intention to cure 3. The patient must be treatable by a radiotherapy technique which can be used in both arms of the trial 4. The patient should have no other concurrent or previous malignant disease likely to interfere with protocol treatment or comparisons 5. Adequate follow-up possible 6. Written informed consent
Exclusion criteria
Exclusion criteria: 1. Distant metastases beyond regional nodes in the neck. 2. Time from surgery to commencement of radiotherapy greater than 70 days. 3. Unable to tolerate protocol treatments
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome measure, which will be used to evaluate the efficacy of the treatment regimens, will be time to local recurrence. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Length of survival 2. Morbidity/toxicity (see form CH03/7) 3. Quality of life (EORTC QLQ H&N 35 Pro forma, CH03/QoL) | — |
Countries
United Kingdom
Outcome results
None listed